China Biologic certified to start commercial manufacturing human coagulation factor VIII

China Biologic Products, Inc. (NASDAQ: CBPO, “China Biologic” or the “Company”) on Oct. 24, 2012 announced that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd. (Taibang) has received good manufacturing practice (GMP) certification from the China State Food and Drug Administration (SFDA) for Human Coagulation Factor VIII (FVIII). Taibang earlier received manufacturing approval for FVIII from the SFDA in June 2012. With now both the manufacturing approval and the GMP certificate, Taibang expects start commercial manufacture of FVIII products immediately.

FVIII is widely used in the treatment of hemophilia A. In China, there is a large hemophilia patient population (estimated at 60,000 – 100,000 afflicted with approximately 10,000 patients registered) whose treatment requires lifelong medication. Currently, only three domestic companies produce plasma-based FVIII products. Taibang is in the process to build additional manufacturing line capacity for FVIII in order to mitigate the situation of China’s large under-supply of coagulation products.

Mr. David Gao, Chairman & CEO, said, “We are immensely encouraged by this latest development at Taibang and are proud to now offer the market all three major categories of blood products through the addition of coagulation factor products. To supply FVIII will significantly improve the market penetration of our plasma-based offering and further strengthen our competitive position as one of China’s top plasma-based biopharmaceutical companies.”

China Biologic is a leading fully integrated plasma-based biopharmaceutical company in China. The Company’s products are used as critical therapies during medical emergencies and for the prevention and treatment of life-threatening diseases and immune-deficiency related diseases. China Biologic is headquartered in Beijing and manufactures over 20 plasma-based products through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co., Ltd. and Guiyang Dalin Biologic Technologies Co., Ltd. The Company also has an equity investment in Xi’an Huitian Blood Products Co., Ltd. The Company sells its products to hospitals and other healthcare facilities in China. For additional information, please see the Company’s website http://www.chinabiolo

Source: http://www.prnewswire.com/news-releases/china-biologic-receives-gmp-certificate-for-human-coagulation-factor-viii-to-start-commercial-manufacturing-this-month-175585251.html

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